Acute Myeloid Leukemia
Conditions
Brief summary
A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of Itraconazole as an adjuvant therapy in treatment of patients with acute myeloid Leukemia.
Interventions
DRUGStandard care +itraconazole 200mg
Is an antifungal used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals.
DRUGChemotherapy
Standard Care (in control arm)
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients with Acute Myeloid leukemia, and aged 18 years or older 2. Patients whose ECOG performance status ranged from 0-2 and are fit for all treatments protocols
Exclusion criteria
1. Patients with any other types of malignancies rather than Leukemia and patients. 2. Patients with history alcohol intake, acute or chronic. 3. Patients with documented hypersensitivity or allergy to Itraconazole. 4. Patients suffer from chronic heart failure 5. Patients present with severe dehydration. 6. Patients with severe kidney dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of blasts in bone marrow at d21 after induction | 8 weeks |
Countries
Egypt
Contacts
Primary ContactGayda A.R. Abuhammad, MSc
Outcome results
None listed